Rotator Cuff InjuryNCT02388477
Trial of the Use of Doxycycline After Rotator Cuff Repair
A study testing Doxycycline and sugar pill in people with Rotator Cuff Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Doxycycline and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- repair of rotator cuff
- age 18 and above
- able to swallow capsules
Who cannot join
- less than 18
- unable to read or understand consent form
- unable to swallow capsules
- allergy to doxycycline
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.
Read the detailed description
Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.
- Conditions
- Rotator Cuff Injury
- Being tested
- Doxycycline, sugar pill
- Keywords
- rotator cuff repair, Doxycycline
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Oracea,, Doryx, Monodox, Vibra-Tabs
antibiotic used to treat infection
sugar pillDrug
placebo with no pharmacologic effect
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | oral doxycycline, 2 weeks, twice a day, Receives: Drug: Doxycycline |
| sugar pill | Placebo comparator | sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks. Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
rotator cuff ultrasound of post-operative shoulder
An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.
Measured: one year
Secondary outcomes (1)
American Shoulder and Elbow Surgeons score
The survey is a standardized assessment of shoulder pain and function from the patient's perspective.
Measured: 6 weeks, 3mos, 6mos, 1yr and 2 yr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Primary completionMay 2016 (estimated)
Why it stopped: Research idea tabled at this point.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aman Dhawan, MD, Milton S. Hershey Medical Center
- Investigators
- Aman Dhawan, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388477
- Sponsor's protocol ID
- STUDY00002143
- Status last verified
- May 2016
- First submitted
- 3 Mar 2015
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT02388477
- Acronym / sponsor ID
- STUDY00002143
- Conditions
- Rotator Cuff Injury
- Keywords
- rotator cuff repair, Doxycycline
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research idea tabled at this point.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Primary completion
- May 2016 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.
Detailed description
Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: Doxycyclineoral doxycycline, 2 weeks, twice a day, |
| sugar pill | Placebo comparator | Drug: sugar pillsugar pill, same size, shape, and color as comparator, twice a day for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- repair of rotator cuff
- age 18 and above
- able to swallow capsules
Key exclusion criteria (4 listed)
- less than 18
- unable to read or understand consent form
- unable to swallow capsules
- allergy to doxycycline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Oracea,, Doryx, Monodox, Vibra-Tabsantibiotic used to treat infection | Drug | Doxycycline |
| sugar pillplacebo with no pharmacologic effect | Drug | sugar pill |
Primary outcome
rotator cuff ultrasound of post-operative shoulder
Time frame: one year
An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.
1 secondary outcome
American Shoulder and Elbow Surgeons score
Time frame: 6 weeks, 3mos, 6mos, 1yr and 2 yr.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aman Dhawan, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline and sugar pill in people with Rotator Cuff Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rotator cuff ultrasound of post-operative shoulder (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.